Cook Medical Recalls Zilver Biliary Stent Due to Incorrect Removal Instructions
Cook Medical is recalling 9,834 Zilver Biliary 518 Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation error (incorrect IFU) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver Biliary 518 Stent (5mm x 60mm, Catalog Number: ZIB5-125-5.0-60). The recall is due to an error in the instruction for use (IFU) concerning the removal of the delivery system during the deployment of the stent. The company is correcting the IFU to amend these instructions.
The affected stents are intended for the palliation of malignant neoplasms in the biliary tree. The recall covers units distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico.
The recall is classified as Class II by the FDA. No specific instructions for consumers are provided in the source text, but the correction of the IFU is the primary remedial action.
The recalled product
- Product
- Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Biliary Stent
- Hazard
- Affected units
- 9,834
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GPN: G36015
Distribution
Part of a larger recall action
This product is one of 39 recalled by Cook Medical Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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